WO2022133105A1 - Déconnexion stérile de systèmes de bioprocédé et son procédé d'utilisation - Google Patents

Déconnexion stérile de systèmes de bioprocédé et son procédé d'utilisation Download PDF

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Publication number
WO2022133105A1
WO2022133105A1 PCT/US2021/063840 US2021063840W WO2022133105A1 WO 2022133105 A1 WO2022133105 A1 WO 2022133105A1 US 2021063840 W US2021063840 W US 2021063840W WO 2022133105 A1 WO2022133105 A1 WO 2022133105A1
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WO
WIPO (PCT)
Prior art keywords
bioprocess
separating
tube
collar
separating collar
Prior art date
Application number
PCT/US2021/063840
Other languages
English (en)
Inventor
Julianna CANNELL
Original Assignee
Lonza Biologics Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lonza Biologics Inc. filed Critical Lonza Biologics Inc.
Priority to CN202180085213.7A priority Critical patent/CN116601288A/zh
Priority to US18/257,156 priority patent/US20240026264A1/en
Priority to EP21848354.3A priority patent/EP4244330A1/fr
Priority to KR1020237023869A priority patent/KR20230122078A/ko
Priority to JP2023562456A priority patent/JP2024500185A/ja
Publication of WO2022133105A1 publication Critical patent/WO2022133105A1/fr

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M47/00—Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass
    • C12M47/12—Purification
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/26—Constructional details, e.g. recesses, hinges flexible
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26D—CUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D3/00—Cutting work characterised by the nature of the cut made; Apparatus therefor
    • B26D3/16—Cutting rods or tubes transversely
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/02—Form or structure of the vessel
    • C12M23/06—Tubular
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/02—Form or structure of the vessel
    • C12M23/14—Bags
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/28—Constructional details, e.g. recesses, hinges disposable or single use
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/40—Manifolds; Distribution pieces
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/44—Multiple separable units; Modules
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/58—Reaction vessels connected in series or in parallel
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus

Definitions

  • Bioreactors which are apparatuses in which biological reactions or processes can be carried out on a laboratory or industrial scale, are used widely within the biopharmaceutical industry. Bioreactors can be used to produce all different types of bioproducts. Bioproducts can include, for instance, cell cultures and materials derived from cell cultures including vaccines, beverages, biofuels, bioenergy, biochemicals, antibiotics, amino acids, enzymes, monoclonal antibodies, monomers, proteins, food cultures, biopolymers, alcohols, flavorings, fragrances, and the like.
  • Cell cultures are typically grown in batch processes where the biological material remains in the bioreactor until the end of the reaction time.
  • fluid medium contained within the bioreactor can be periodically or continuously removed and resupplied in order to replenish nutrients contained within the fluid medium and for possibly removing damaging by-products that are produced during the process.
  • fluids are formulated and fed to different process equipment.
  • Such fluids can include nutrient mediums, various different types of reagents, buffer formulations, and the like.
  • fluids are also conveyed between different process components.
  • cell cultures are typically grown in bioreactors and then fed downstream to different purification processes.
  • the purification processes can include chromatography skids, filtration devices, and the like.
  • Each of these different steps of the process can also produce product and byproduct streams that are removed during the process and stored in different containers, such as bioprocess bags.
  • the present disclosure is generally directed to a system and method for growing, harvesting and purifying cell cultures and bioproducts produced therefrom. More particularly, the present disclosure is directed to a bioprocess system and method capable of producing relatively large batches of biological materials. The components contained within the system are all sized for high throughputs in order to produce all different types of beneficial bioproducts, including vaccines for different viruses.
  • the bioprocess method and system include relatively large bioprocess tubes that convey fluids and connect the different components.
  • the present disclosure is directed to a method of disconnecting the bioprocess tubes after fluid flow in an efficient and sterile manner.
  • the present disclosure is directed to a bioprocess system comprising a first bioprocess device and a second bioprocess device.
  • a bioprocess tube is in fluid communication with the first bioprocess device and the second bioprocess device.
  • the bioprocess tube comprises a thermoplastic elastomer.
  • the bioprocess tube defines a hollow passageway having an internal diameter, an external diameter, and an external surface.
  • the internal diameter of the bioprocess tube is greater than about 260 mm, such as greater than about 280 mm, such as greater than about 300 mm, such as greater than about 320 mm, such as greater than about 340 mm, such as greater than about 360 mm, such as greater than about 380 mm, such as greater than about 400 mm.
  • the system further includes a separating collar for facilitating cutting of the bioprocess tube for disconnecting the first bioprocess device from the second bioprocess device.
  • the separating collar is slidably mounted on the exterior surface of the bioprocess tube.
  • the separating collar has a cylindrical shape and has a length that extends from a first end to a second and opposite end.
  • the separating collar is made from a rigid and malleable material.
  • the separating collar defines at least one pair of adjacent separating edges that extend over the length of the collar.
  • the pair of adjacent separating edges allow the separating collar to be installed and removed from a bioprocess tube. For instance, in one aspect, pair of adjacent separating edges form a slit that extends over the length of the collar.
  • the separating device can be made from various different materials, such as metallic materials, polymer materials, and the like.
  • the separating collar can be made from a single layer of material or can be made from multiple layers of material. In one embodiment, the separating collar can be made from aluminum.
  • a cutting device is used to cut the separating collar and the underlying tube. During cutting, the separating collar and bioprocess tube are compressed.
  • the separating collar is made from a material with sufficient rigidity and malleability such that after cutting the bioprocess tube, the separating collar maintains the open ends of the bioprocess tube in a closed configuration. Consequently, the separating collar is made from a material that is able to withstand the natural biasing forces of the bioprocess tube once the clamping action of the cutting tool is released.
  • the separating collar can define a slit along the length of the collar.
  • the slit can have a width, in one aspect, of greater than about 0.5 mm, such as greater than about 1 mm, such as greater than about 1.5 mm, such as greater than about 2 mm, and less than about 5 mm, such as less than about 3 mm.
  • the slit can be wider.
  • the slit can have a width of greater than about 3 mm, such as greater than about 10 mm, such as greater than about 20 mm, such as greater than about 30 mm, and generally less than about 100 mm.
  • the slit should have a width that facilitates opening the collar so as to place the collar around a bioprocess tube.
  • the length of the separating collar can generally be from about 600 mm to about 3000 mm.
  • the opposite ends of the separating collar can overlap along the slit.
  • the opposite free ends of the separating collar can overlap by greater than about 1 mm, such as greater than about 5mm, and generally less than about 300 mm, such as less than about 15 mm.
  • the separating collar comprises a first collar member and a separate second collar member.
  • the first and second collar members cooperate together to form the cylindrical shape.
  • the separating collar can form two pairs of adjacent separating edges where the first collar member intersects the second collar member.
  • the present disclosure is also directed to a process for separating a bioprocess tube contained in a bioprocess.
  • the method includes placing a separating collar on an exterior surface of a bioprocess tube.
  • the bioprocess tube is made from a thermoplastic elastomer and has an internal diameter of greater than about 260 mm, such as greater than about 300mm.
  • the separating collar is slidably mounted on the exterior surface of the bioprocess tube.
  • the separating collar has a cylindrical shape having a length. At least one pair of adjacent separating edges extend over the length of the separating collar. The pair of adjacent separating edges is for allowing the separating collar to be installed and removed from the bioprocess tube.
  • the method further includes the step of cutting through the separating collar and the bioprocess tube to produce a first free end and a second free end. During cutting, the separating collar and underlying bioprocess tube are deformed, compressing the walls of the bioprocess tube together at each free end.
  • the separating collar is made from a material with sufficient rigidity and malleability to maintain the open ends of the bioprocess tube in a closed state or condition.
  • the method can further include the step of blocking flow of fluid through the bioprocess tube upstream of the separating device using a flow stop device and blocking flow of fluids through the bioprocess tube downstream of the separating device using a second flow stop device.
  • the flow stop devices for instance, can comprise clamps and can be installed on each side of the separating device prior to cutting the bioprocess tube.
  • the present disclosure is also directed to a bioprocess apparatus comprising a separating collar as described above removably and slidably mounted on a bioprocess tube having an internal diameter greater than about 260 mm.
  • FIG. 1 is a schematic diagram of one embodiment of a bioreactor system that can be used in conjunction with the present disclosure
  • FIG. 2 is a perspective view with cut away portions of one embodiment of a bioreactor apparatus made in accordance with the present disclosure
  • FIG. 3 is a cross-sectional view of a bioprocess tube that may be used in accordance with the present disclosure
  • FIG. 4 is a perspective view of one embodiment of a cutting device in conjunction with a bioprocess apparatus of the present disclosure illustrating one manner in which the bioprocess tube may be cut;
  • Fig. 5 is a perspective view with cut away portions of the bioprocess apparatus of the present disclosure after a cut has been made;
  • FIG. 6 is a perspective view with cut away portions of another embodiment of a bioreactor apparatus made in accordance with the present disclosure
  • Fig. 7 is a cross-sectional view of the bioprocess apparatus illustrated in Fig. 6;
  • FIG. 8 is a perspective view of an embodiment of a separating collar made in accordance with the present disclosure shown in a disassembled configuration
  • Fig. 9 is a perspective view of the separating collar illustrated in Fig. 8 shown in an assembled configuration.
  • the present disclosure is directed to a system and method for propagating cell cultures, harvesting the cell cultures, purifying the cell cultures and producing a biological product.
  • Many different types of biological products can be produced according to the present disclosure.
  • the biological product can be a protein or any other metabolite produced by the cell culture.
  • the cell culture can be used to produce a vaccine for viruses, such as recombinant messenger RNA.
  • a major obstacle to the production of biologies, such as vaccines is the ability to produce the biological products on a larger scale in a reliable manner.
  • various obstacles can exist that may reduce efficiencies.
  • mid-scale and large-scale bioprocess systems need bioprocess tubes that have larger sizes and diameters for connecting the different components together.
  • the present disclosure is directed to an efficient way to disconnect larger bioprocess tubes after fluid flow in order to isolate a component in the system and/or to collect a product or a byproduct in, for instance, a bioprocess bag.
  • Fig. 1 illustrates one example of a bioprocess system that may incorporate the elements of the present disclosure for connecting and disconnecting the various different components and bioprocess devices.
  • the bioreactor system includes a bioreactor 10.
  • the bioreactor may comprise a fermenter, a stirred-tank reactor, an adherent bioreactor, a wave-type bioreactor, a disposable bioreactor, and the like.
  • the bioreactor 10 comprises a hollow vessel or container that includes a bioreactor volume 12 for receiving a cell culture within a fluid growth medium.
  • the bioreactor system can further include a rotatable shaft 14 coupled to an agitator such as dual impellers 16 and 18 and to a motor 24.
  • the bioreactor 10 can be made from various different materials.
  • the bioreactor 10 can be made from metal, such as stainless steel.
  • the bioreactor 10 may comprise a single use bioreactor made from a rigid polymer or a flexible polymer film.
  • the bioreactor 10 can have any suitable volume. In general, however, the bioreactor 10 has a volume of greater than about 5 L, such as greater than about 50 L, such as greater than about 100 L, such as greater than about 500 L, such as greater than about 700 L, such as greater than about 1000 L, such as greater than about 1500 L, such as greater than about 2000 L, such as greater than about 2500 L, such as greater than about 3000 L, such as greater than about 3500 L, such as greater than about 4000 L, such as greater than about 4500 L, such as greater than about 5000 L.
  • the volume of the bioreactor 10 can be even greater than about 7000 L, such as greater than about 10,000 L, such as greater than about 15,000 L, such as greater than about 20,000 L.
  • the volume of the bioreactor 10 is generally less than about 50,000 L, such as less than about 30,000 L.
  • the bioreactor 10 can include various additional equipment, such as baffles, spargers, gas supplies, heat exchangers or thermal circulator ports, and the like which allow for the cultivation and propagation of biological cells.
  • additional equipment such as baffles, spargers, gas supplies, heat exchangers or thermal circulator ports, and the like which allow for the cultivation and propagation of biological cells.
  • the bioreactor 10 includes a sparger 20 and a baffle 22.
  • the bioreactor 10 also includes a plurality of ports.
  • the ports can allow supply lines and feed lines into and out of the bioreactor 10 for adding and removing fluids and other materials.
  • the one or more ports may be for connecting to one or more probes for monitoring conditions within the bioreactor 10.
  • the bioreactor 10 and be placed in association with a load cell for measuring the mass of the culture within the bioreactor.
  • the bioreactor 10 includes a bottom port 26 connected to an effluent 28 for withdrawing materials from the bioreactor continuously or periodically. Materials can be withdrawn from the bioreactor 10 using any suitable method. For instance, in an alternative embodiment, an effluent can be removed from the bioreactor 10 from the top of the bioreactor using a dip tube.
  • the bioreactor 10 includes a plurality of top ports, such as ports 30, 32, and 34. Port 30 is in fluid communication with a first fluid feed 36, port 32 is in fluid communication with a second feed 38 and port 34 is in fluid communication with a third feed 40. The feeds 36, 38 and 40 are for feeding various different materials to the bioreactor 10, such as a nutrient media.
  • the bioreactor can be in communication with multiple nutrient feeds.
  • a nutrient media can be fed to the bioreactor containing only a single nutrient for better controlling the concentration of the nutrient in the bioreactor during the process.
  • the different feed lines can be used to feed gases and liquids separately to the bioreactor.
  • the cell culture is fed to a harvest system for harvesting a bioproduct.
  • the system may include a harvest tank, and a centrifuge.
  • the bioproduct being harvested can then be fed to downstream purification processes.
  • the bioproduct harvested from the bioreactor 10 can be fed to a first filtration device 42, a chromatography device 44, and a second filtration device 46.
  • the system illustrated in Fig. 1 is merely exemplary and the system can include more than one chromatography device, less than two filtration devices or more than two filtration devices as desired.
  • the filtration devices 42 and 46 may include a variety of filtration mechanisms.
  • one of the filtration devices may comprise a tangential flow filtration (TFF) device.
  • a tangential flow filtration device may enable the diafiltration of the product stream.
  • a tangential flow filtration device may include two stages; volume reduction and diafiltration. During the volume reduction step, the bulk volume of the cell culture medias is filtered out through the permeate side of the filter until a desired product concentration is reached in the holding tank. In a diafiltration stage following the volume reduction stage, the concentrated product is washed with a fluid, such as a buffer, to remove cell culture or harvest media components that are undesired or are unacceptable. Further volume reduction may also be carried out after diafiltration to reach a desired product density.
  • a fluid such as a buffer
  • the filtration devices 42 and 46 may use ultrafiltration. During ultrafiltration, the product stream is fed through a semipermeable membrane. Suspended solids and solutes of high molecular weight are retained as a retentate, while water and low molecular weight solutes pass through the membrane as the permeate. Ultrafiltration is particularly well suited to purifying and concentrating protein solutions. In one embodiment, ultrafiltration can be used with diafiltration as described above.
  • the chromatography device 44 as shown in Fig. 1 may use various different chromatography methods such as affinity chromatography, gel filtration chromatography, ion exchange chromatography, reversed phase chromatography, hydrophobic interaction chromatography, and the like.
  • the chromatography device 44 may also need a buffer for proper operation of the device.
  • the system can further include a buffer device 60 that stores and/or formulates buffers for feeding to the different components.
  • the system can further include a controller 70.
  • the controller may comprise one or more programmable devices or microprocessors. As shown, the controller 70 can be in communication with the one or more feeds 36, 38 and 40 and with one or more effluents 28.
  • bioprocess devices can be incorporated into the system.
  • the system can include membrane devices, cation exchange devices, virus reduction filtration devices, and the like.
  • each of the bioprocess devices can be in fluid communication with each other using various different bioprocess tubes 110.
  • various different bioprocess devices contained within the system can also produce a byproduct stream that can be collected in a bioprocess container or bag.
  • a bioprocess tube can provide fluid commination between the bioprocess container and the other bioprocess device.
  • the present disclosure is generally directed to a bioprocess apparatus that can efficiently disconnect one bioprocess device from another bioprocess device at any location along a bioprocess tube that was previously used to connect the devices for fluid flow.
  • the bioprocess apparatus of the present disclosure is particularly well suited to forming disconnects on bioprocess tubes that are used in mid-scale and large-scale systems. More particularly, the bioprocess apparatus is designed to form a separation along a bioprocess tube that has a relatively large internal diameter.
  • the bioprocess device can be used to produce a sterile disconnect along the bioprocess tube.
  • the bioprocess apparatus 112 includes a bioprocess tube 110 in combination with a separating collar 120. Referring to Fig. 3, a cross-sectional view of the bioprocess tube 110 is illustrated.
  • the bioprocess tube 110 defines an interior passageway 124 that is surrounded by an interior surface 118.
  • the bioprocess tube 110 includes a wall thickness 114 that also defines an exterior surface 116.
  • the bioprocess tube 110 can be made from a polymer material, particularly a thermoplastic polymer.
  • the bioprocess tube 110 is made from a thermoplastic elastomer.
  • the bioprocess tube 110 can be made from a silicone polymer.
  • Other elastomers that may be used to produce the bioprocess tube include polyvinyl chloride polymers, polypropylene polymers, polyethylene polymers, or a polyester polymer.
  • a polymer can refer to a homopolymer, a copolymer, a block copolymer, a random copolymer, a terpolymer, and the like.
  • polypropylene elastomers can be used that contain a polypropylene homopolymer combined with a polypropylene random copolymer.
  • the polymer composition used to produce the bioprocess tube 110 can contain a plasticizer.
  • the bioprocess tube 110 has a relatively large size capable of conveying significant fluid flow therethrough.
  • the bioprocess tube 110 can have an internal diameter measured from the interior surface 118 and an exterior diameter measured from the exterior surface 116.
  • the internal diameter of the bioprocess tube 110 in accordance with the present disclosure is greater than about 260 mm.
  • the internal diameter of the bioprocess tube 110 can be greater than about 300 mm, such as greater than about 350 mm, such as greater than about 400 mm, such as greater than about 450 mm, such as greater than about 500 mm, such as greater than about 550 mm, such as greater than about 600 mm, such as greater than about 650, such as greater than about 700 mm, such as greater than about 750 mm, such as greater than about 800 mm, such as greater than about 850 mm, such as greater than about 900 mm, such as greater than about 950 mm, such as greater than about 1000 mm.
  • the internal diameter of the bioprocess tube 110 is generally less than about 2000 mm, such as less than about 1500 mm. In one particular aspect, the internal diameter of the bioprocess tube 110 is from about 260 mm to about 780 mm, including all increments of 5 mm therebetween.
  • the wall thickness 114 of the bioprocess tube 110 can vary depending upon various factors including the type of thermoplastic polymer used to make the bioprocess tube, and the amount of pressure that may build up within the bioprocess tube 110 during operation. In general, the wall thickness 114 is generally greater than about 5mm, such as greater than about 6mm, such as greater than about 7 mm, and generally less than about 12 mm, such as less than about 10 mm, such as less than about 8 mm.
  • the separating collar 120 of the present disclosure is shown mounted on the exterior surface 116 of the bioprocess tube 110.
  • the separating collar 120 generally has a cylindrical shape that is designed to accommodate the outside diameter of the bioprocess tube 110.
  • the separating collar 120 includes a pair of adjacent separating edges that define a slit 122 that extends along the length of the separating collar 120 from a first end to a second and opposite end.
  • the opposing ends of the separating collar 120 along the slit 122 can overlap.
  • the separating collar 120 defines a slit 122.
  • the opposite ends or edges of the separating collar 120 overlap along the slit 122.
  • the amount of overlap can depend upon various factors. In general, the opposite ends overlap greater than about 1 mm, such as greater than about 5 mm, such as greater than about 8 mm, such as greater than about 10 mm.
  • the amount the opposite ends overlap is generally less than about 300 mm, such as less than about 200 mm, such as less than about 100 mm, such as less than about 50 mm, such as less than about 25 mm, such as less than about 15 mm.
  • the slit 122 can have various different purposes.
  • the slit 122 allows the separating collar 120 to be fitted over bioprocess tubes 110 that have different external diameters.
  • the slit 122 can be used to place the separating collar 120 onto the exterior surface 116 of the bioprocess tube 110. For instance, by grasping opposite ends of the separating collar 120 along the slit 122, one can increase the size of the slit so that the separating collar 120 can be placed over the bioprocess tube 110.
  • a device or tool made be used that can engage opposite ends of the separating collar along the slit 122 for providing the force necessary for the slit to open up for accommodating a bioprocess tube.
  • the separating collar can be manufactured in an open state allowing the collar to be placed over a bioprocess tube. Once placed over the bioprocess tube, the separating collar can then be bended into a desired shape that conforms to the exterior surface of the bioprocess tube.
  • the slit 122 also allows the separating device 120 to be slidably mounted onto the bioprocess tube 110. In this manner, the separating collar 120 can be moved to any desired location on the bioprocess tube.
  • the ability to slide the separating collar 120 over the exterior surface 116 of the bioprocess tube 110 provides significant flexibility in determining later the best location to separate the bioprocess tube after fluid flow has stopped.
  • the width of slit 122 along the length of the separating collar 120 can vary depending upon the type of material used to produce the separating collar 120, the outside diameter of the bioprocess tube 110, and the like.
  • the slit 122 can be relatively narrow.
  • the slit can have a width of less than about 3 mm, such as less than about 2 mm, such as less than about 1 .5 mm, such as less than about 1 mm, and generally greater than about 0.5 mm, such as greater than about 1 mm.
  • the slit can be wider, especially when the separating collar 120 is to be installed on larger bioprocess tubes.
  • the width of the slit can be greater than about 3 mm, such as greater than about 10 mm, such as greater than about 20 mm, such as greater than about 30 mm, and generally less than about 100 mm.
  • the length of the separating collar 120 and therefore the length of the slit can generally be anywhere from about 600 mm to about 10,000 mm and including all increments of 5 mm therebetween.
  • the length of the separating collar 120 should be sufficient to maintain the bioprocess tube in a closed condition after cutting as will be explained in greater detail below.
  • the upper boundary of the length is not a factor and there may be applications where the length can be greater than about 3000 mm, such as greater than about 5000 mm, such as greater than about 10,000 mm, such as greater than about 15,000 mm.
  • the separating collar is made from a single, integral piece of material that includes a single pair of adjacent separating edges that define a slit. In other embodiments, however, the separating collar can be made from multiple pieces of material.
  • a separating collar 120 is illustrated that includes a first collar member 134 a second collar member 136.
  • the first collar member 134 and the second collar member 136 are capable of being attached together as shown particularly in Fig. 9.
  • the separating collar 120 as shown in Fig. 9 defines a first pair of adjacent separating edges 146 and a second pair of adjacent separating edges 148.
  • the first collar member 134 and the second collar member 136 are capable of being attached together along the separating edges 146 and 148.
  • any suitable attachment device can be used in order to connect the first collar member 134 to the second collar member 136.
  • the first collar member 134 includes curled edges 140 and 144 that are adapted to engage curled edges 138 and 142 on the second collar member 136. It should be understood, however, that any male and female connection can be made between the collar members 134 and 136 along their adjacent edges.
  • first collar member 134 can be connected to the second collar member 136 along a hinge at a first pair of adjacent separating edges.
  • the second pair of adjacent separating edges can include a connecting device that permits the two edges to connect.
  • the bioprocess tube 110 in Fig. 4 can provide fluid communication between two different bioprocess devices.
  • the bioprocess tube 110 can be used for fluid transfer between the two devices. After fluid transfer has terminated, in many operations, it is desirable to disconnect the first bioprocess device from the second bioprocess device.
  • the bioprocess apparatus of the present disclosure provides for an efficient and convenient way to disconnect the two devices from each other.
  • the separating collar 120 is first slidably mounted onto the bioprocess tube 110.
  • the separating collar 120 can then be moved to any desired location where a disconnect operation can take place.
  • a cutting tool 150 as shown in Fig. 4 can then be used to cut through both the separating device 120 and the underlying bioprocess tube 110.
  • the cutting tool 150 is a handheld device. In other embodiments, however, a motorized device may also be used.
  • a cutting device 150 is used that compresses the separating collar 120 and bioprocess tube 110 while simultaneously cutting through both materials.
  • the cutting device 150 can deform the separating device 120 and compress the bioprocess tube squeezing the interior wall of the bioprocess tube together.
  • the cutting device 150 cuts through both materials and forms a first free end 130 and a second free end 132 as shown in Fig. 5.
  • the separating collar 120 made in accordance with the present disclosure is made from a material with sufficient malleability and rigidity to deform during cutting and then maintain each free end 130 and 132 in a closed condition. In this manner, the bioprocess apparatus of the present disclosure can produce a sterile disconnect and even an aseptic seal.
  • flow stop devices can be installed upstream and downstream from the separating collar 120.
  • the flow stop device can be any suitable clamp capable of cutting off fluid flow through the bioprocess tube 110.
  • the material used to produce the separating collar 120 should be selected so that the separating collar 120 can be fitted over a bioprocess tube, can be compressed during a cutting process, and can maintain the free ends formed during the cutting process in a closed position.
  • the separating collar 120 for instance, can be made from a polymer material, a reinforced polymer material, a metal, or mixtures thereof.
  • the separating collar 120 can be made from a single layer of material or can have a multilayer design.
  • the separating collar 120 is made from a metal, such as an aluminum.
  • the thickness of the separating collar 120 can generally be greater than about 0.5 mm, such as greater than about 0.75 mm, such as greater than about 1 mm, such as greater than about 1.1 mm, such as greater than about 1.2 mm, such as greater than about 1 .3 mm, such as greater than about 1 .4 mm, such as greater than about 1 .5 mm.
  • the thickness is generally less than about 4 mm, such as less than about 3 mm, such as less than about 2 mm, such as less than about 1.8 mm.
  • the separating device 120 can be used at any desired location within a bioprocess system, such as any place shown in the bioprocess system of Fig. 1.
  • the separating collar can be used to disconnect a bioreactor from any upstream or downstream bioprocess device.
  • the separating collar for instance, can be used to disconnect a bioreactor from a media supply, buffer supply, gas supply, or the like.
  • the separating collar can also be used to disconnect a bioreactor from a downstream device, such as a filtration device.
  • the separating collar can also be used during harvesting and purification.
  • the separating device can be used to separate a chromatography device from a filtration device or a filtration device from a process bag.
  • the devices, facilities and methods described herein are suitable for culturing any desired cell line including prokaryotic and/or eukaryotic cell lines. Further, in embodiments, the devices, facilities and methods are suitable for culturing suspension cells or anchorage-dependent (adherent) cells and are suitable for production operations configured for production of pharmaceutical and biopharmaceutical products — such as polypeptide products, nucleic acid products (for example DNA or RNA), or cells and/or viruses such as those used in cellular and/or viral therapies.
  • pharmaceutical and biopharmaceutical products such as polypeptide products, nucleic acid products (for example DNA or RNA), or cells and/or viruses such as those used in cellular and/or viral therapies.
  • the cells express or produce a product, such as a recombinant therapeutic or diagnostic product.
  • a product such as a recombinant therapeutic or diagnostic product.
  • products produced by cells include, but are not limited to, antibody molecules (e.g., monoclonal antibodies, bispecific antibodies), antibody mimetics (polypeptide molecules that bind specifically to antigens but that are not structurally related to antibodies such as e.g.
  • DARPins affibodies, adnectins, or IgNARs
  • fusion proteins e.g., Fc fusion proteins, chimeric cytokines
  • other recombinant proteins e.g., glycosylated proteins, enzymes, hormones
  • viral therapeutics e.g., anti-cancer oncolytic viruses, viral vectors for gene therapy and viral immunotherapy
  • cell therapeutics e.g., pluripotent stem cells, mesenchymal stem cells and adult stem cells
  • vaccines or lipid-encapsulated particles e.g., exosomes, virus-like particles
  • RNA such as e.g. siRNA
  • DNA such as e.g. plasmid DNA
  • antibiotics or amino acids antibiotics or amino acids.
  • the devices, facilities and methods can be used for producing biosimilars.
  • devices, facilities and methods allow for the production of eukaryotic cells, e.g., mammalian cells or lower eukaryotic cells such as for example yeast cells or filamentous fungi cells, or prokaryotic cells such as Gram-positive or Gram-negative cells and/or products of the eukaryotic or prokaryotic cells, e.g., proteins, peptides, antibiotics, amino acids, nucleic acids (such as DNA or RNA), synthesised by the eukaryotic cells in a large-scale manner.
  • the devices, facilities, and methods can include any desired volume or production capacity including but not limited to bench-scale, pilot-scale, and full production scale capacities.
  • the devices, facilities, and methods can include any suitable reactor(s) including but not limited to stirred tank, airlift, fiber, microfiber, hollow fiber, ceramic matrix, fluidized bed, fixed bed, and/or spouted bed bioreactors.
  • suitable reactor(s) including but not limited to stirred tank, airlift, fiber, microfiber, hollow fiber, ceramic matrix, fluidized bed, fixed bed, and/or spouted bed bioreactors.
  • reactor can include a fermentor or fermentation unit, or any other reaction vessel and the term “reactor” is used interchangeably with “fermentor.”
  • an example bioreactor unit can perform one or more, or all, of the following: feeding of nutrients and/or carbon sources, injection of suitable gas (e.g., oxygen), inlet and outlet flow of fermentation or cell culture medium, separation of gas and liquid phases, maintenance of temperature, maintenance of oxygen and CO2 levels, maintenance of pH level, agitation (e.g., stirring), and/or cleaning/sterilizing.
  • Example reactor units such as a fermentation unit, may contain multiple reactors within the unit, for example the unit can have 1 , 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, or 100, or more bioreactors in each unit and/or a facility may contain multiple units having a single or multiple reactors within the facility.
  • the bioreactor can be suitable for batch, semi fed-batch, fed-batch, perfusion, and/or a continuous fermentation processes. Any suitable reactor diameter can be used.
  • the bioreactor can have a volume between about 100 mL and about 50,000 L.
  • Non-limiting examples include a volume of 100 mL, 250 mL, 500 mL, 750 mL, 1 liter, 2 liters, 3 liters, 4 liters, 5 liters, 6 liters, 7 liters, 8 liters, 9 liters, 10 liters, 15 liters, 20 liters, 25 liters, 30 liters, 40 liters, 50 liters, 60 liters, 70 liters, 80 liters, 90 liters, 100 liters, 150 liters, 200 liters, 250 liters, 300 liters, 350 liters, 400 liters, 450 liters, 500 liters, 550 liters, 600 liters, 650 liters, 700 liters, 750 liters, 800 liters, 850 liters, 900 liters, 950 liters, 1000 liters, 1500 liters, 2000 liters, 2500 liters, 3000 liters, 3
  • suitable reactors can be multi-use, single-use, disposable, or non-disposable and can be formed of any suitable material including metal alloys such as stainless steel (e.g., 316L or any other suitable stainless steel) and Inconel, plastics, and/or glass.
  • the devices, facilities, and methods described herein can also include any suitable unit operation and/or equipment not otherwise mentioned, such as operations and/or equipment for separation, purification, and isolation of such products.
  • Any suitable facility and environment can be used, such as traditional stick-built facilities, modular, mobile and temporary facilities, or any other suitable construction, facility, and/or layout. For example, in some embodiments modular clean-rooms can be used.
  • the devices, systems, and methods described herein can be housed and/or performed in a single location or facility or alternatively be housed and/or performed at separate or multiple locations and/or facilities.
  • the cells are eukaryotic cells, e.g., mammalian cells.
  • the mammalian cells can be for example human or rodent or bovine cell lines or cell strains. Examples of such cells, cell lines or cell strains are e.g.
  • mouse myeloma (NSO)-cell lines Chinese hamster ovary (CHO)-cell lines, HT1080, H9, HepG2, MCF7, MDBK Jurkat, NIH3T3, PC12, BHK (baby hamster kidney cell), VERO, SP2/0, YB2/0, Y0, C127, L cell, COS, e.g., COS1 and COS7, QC1-3.HEK- 293, VERO, PER.C6, HeLA, EBI, EB2, EB3, oncolytic or hybridoma-cell lines.
  • the mammalian cells are CHO-cell lines.
  • the cell is a CHO cell.
  • the cell is a CHO-K1 cell, a CHO-K1 SV cell, a DG44 CHO cell, a DUXB11 CHO cell, a CHOS, a CHO GS knock-out cell, a CHO FUT8 GS knock-out cell, a CHOZN, or a CHO-derived cell.
  • the CHO GS knockout cell e.g., GSKO cell
  • the CHO FUT8 knockout cell is, for example, the Potell igent® CHOK1 SV (Lonza Biologies, Inc.).
  • Eukaryotic cells can also be avian cells, cell lines or cell strains, such as for example, EBx® cells, EB14, EB24, EB26, EB66, or EBvl3.
  • the eukaryotic cells are stem cells.
  • the stem cells can be, for example, pluripotent stem cells, including embryonic stem cells (ESCs), adult stem cells, induced pluripotent stem cells (iPSCs), tissue specific stem cells (e.g., hematopoietic stem cells) and mesenchymal stem cells (MSCs).
  • the cells are for cell therapy.
  • the cells may include T cells, or immune cells.
  • the cells can include B cells, natural killer cells, dendritic cells, tumor infiltrating lymphocytes, monocytes, megakaryocytes, or the like.
  • the cell is a differentiated form of any of the cells described herein. In one embodiment, the cell is a cell derived from any primary cell in culture.
  • the cell is a hepatocyte such as a human hepatocyte, animal hepatocyte, or a non-parenchymal cell.
  • the cell can be a plateable metabolism qualified human hepatocyte, a plateable induction qualified human hepatocyte, plateable Qualyst Transporter CertifiedTM human hepatocyte, suspension qualified human hepatocyte (including 10-donor and 20- donor pooled hepatocytes), human hepatic kupffer cells, human hepatic stellate cells, dog hepatocytes (including single and pooled Beagle hepatocytes), mouse hepatocytes (including CD-1 and C57BI/6 hepatocytes), rat hepatocytes (including Sprague-Dawley, Wistar Han, and Wistar hepatocytes), monkey hepatocytes (including Cynomolgus or Rhesus monkey hepatocytes), cat hepatocytes (including Domestic Shorthair hepat
  • the eukaryotic cell is a lower eukaryotic cell such as e.g. a yeast cell (e.g., Pichia genus (e.g. Pichia pastoris, Pichia methanolica, Pichia kluyveri, and Pichia angusta), Komagataella genus (e.g. Komagataella pastoris, Komagataella pseudopastoris or Komagataella phaffii), Saccharomyces genus (e.g. Saccharomyces cerevisae, cerevisiae, Saccharomyces kluyveri, Saccharomyces uvarum), Kluyveromyces genus (e.g.
  • a yeast cell e.g., Pichia genus (e.g. Pichia pastoris, Pichia methanolica, Pichia kluyveri, and Pichia angusta)
  • Komagataella genus e.g. Koma
  • Pichia pastoris e.g. Candida utilis, Candida cacaoi, Candida boidinii,
  • Geotrichum genus e.g. Geotrichum fermentans
  • Hansenula polymorpha Yarrowia lipolytica, or Schizosaccharomyces pombe, .
  • Pichia pastoris examples are X33, GS115, KM71 , KM71 H; and CBS7435.
  • the eukaryotic cell is a fungal cell (e.g. Aspergillus (such as A. niger, A. fumigatus, A. orzyae, A. nidula), Acremonium (such as A. thermophilum), Chaetomium (such as C. thermophilum), Chrysosporium (such as C. thermophile), Cordyceps (such as C. militaris), Corynascus, Ctenomyces, Fusarium (such as F. oxysporum), Glomerella (such as G. graminicola), Hypocrea (such as H. jecorina), Magnaporthe (such as M.
  • Aspergillus such as A. niger, A. fumigatus, A. orzyae, A. nidula
  • Acremonium such as A. thermophilum
  • Chaetomium such as C. thermophilum
  • Chrysosporium such as C. thermophile
  • Myceliophthora such as M. thermophile
  • Nectria such as N. heamatococca
  • Neurospora such as N. crassa
  • Penicillium such as N. crassa
  • Sporotrichum such as S. thermophile
  • Thielavia such as T. terrestris, T. heterothallica
  • Trichoderma such as T. reesei
  • Verticillium such as V. dahlia
  • the eukaryotic cell is an insect cell (e.g., Sf9, MimicTM Sf9, Sf21 , High FiveTM (BT1-TN-5B1-4), or BT1-Ea88 cells), an algae cell (e.g., of the genus Amphora, Bacillariophyceae, Dunaliella, Chlorella, Chlamydomonas, Cyanophyta (cyanobacteria), Nannochloropsis, Spirulina.or Ochromonas), or a plant cell (e.g., cells from monocotyledonous plants (e.g., maize, rice, wheat, or Setaria), or from a dicotyledonous plants (e.g., cassava, potato, soybean, tomato, tobacco, alfalfa, Physcomitrella patens or Arabidopsis).
  • the cell is a bacterial or prokaryotic cell.
  • the prokaryotic cell is a Gram-positive cells such as
  • Bacillus Streptomyces Streptococcus, Staphylococcus or Lactobacillus.
  • Bacillus that can be used is, e.g. the B.subtilis, B.amyloliquefaciens, B.licheniformis, B.natto, or B.megaterium.
  • the cell is B.subtilis, such as B.subtilis 3NA and B.subtilis 168.
  • Bacillus is obtainable from, e.g., the Bacillus Genetic Stock Center , Biological Sciences 556, 484 West 12th Avenue, Columbus OH 43210-1214.
  • the prokaryotic cell is a Gram-negative cell, such as Salmonella spp. or Escherichia coli, such as e.g., TG1 , TG2, W3110, DH1 , DHB4, DH5a, HMS 174, HMS174 (DE3), NM533, C600, HB101 , JM109, MC4100, XL1-Blue and Origami, as well as those derived from E.coli B-strains, such as for example BL-21 or BL21 (DE3), all of which are commercially available.
  • Suitable host cells are commercially available, for example, from culture collections such as the DSMZ (Deutsche Sammlung von Mikroorganismen and Zellkulturen GmbH, Braunschweig, Germany) or the American Type Culture Collection (ATCC).
  • the cultured cells are used to produce proteins e.g., antibodies, e.g., monoclonal antibodies, and/or recombinant proteins, for therapeutic use.
  • the cultured cells produce peptides, amino acids, fatty acids or other useful biochemical intermediates or metabolites.
  • molecules having a molecular weight of about 4000 daltons to greater than about 140,000 daltons can be produced.
  • these molecules can have a range of complexity and can include posttranslational modifications including glycosylation.
  • the protein is, e.g., BOTOX, Myobloc, Neurobloc, Dysport (or other serotypes of botulinum neurotoxins), alglucosidase alpha, daptomycin, YH-16, choriogonadotropin alpha, filgrastim, cetrorelix, interleukin-2, aldesleukin, teceleulin, denileukin diftitox, interferon alpha-n3 (injection), interferon alpha-nl, DL-8234, interferon, Suntory (gamma-1 a), interferon gamma, thymosin alpha 1 , tasonermin, DigiFab, ViperaTAb, EchiTAb, CroFab, nesiritide, abatacept, alefacept, Rebif, eptoterminalfa, teriparatide (osteoporosis), calcitonin injectable (bone disease
  • the polypeptide is adalimumab (HUMIRA), infliximab (REMICADETM), rituximab (RITUXANTM/MAB THERATM) etanercept (ENBRELTM), bevacizumab (AVASTINTM), trastuzumab (HERCEPTINTM), pegrilgrastim (NEULASTATM), or any other suitable polypeptide including biosimilars and biobetters.
  • HUMIRA adalimumab
  • REMICADETM infliximab
  • rituximab RITUXANTM/MAB THERATM
  • ENBRELTM bevacizumab
  • HERCEPTINTM trastuzumab
  • NEULASTATM pegrilgrastim
  • the polypeptide is a hormone, blood clotting/coagulation factor, cytokine/growth factor, antibody molelcule, fusion protein, protein vaccine, or peptide as shown in Table 2.
  • the protein is multispecific protein, e.g., a bispecific antibody as shown in Table 3.

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Abstract

L'invention divulgue un appareil de bioprocédé qui permet de déconnecter efficacement de grands tubes de bioprocédé d'un système de bioprocédé. L'appareil de bioprocédé comprend un collier de séparation constitué d'un matériau malléable et rigide qui peut être placé sur de grands tubes de bioprocédé. Selon un aspect, le collier de séparation comprend deux bords de séparation adjacents qui permettent un montage coulissant du collier sur un tube de bioprocédé. Une fois positionné sur le tube de bioprocédé, une opération de coupe a lieu, laquelle traverse le collier de séparation et le tube de bioprocédé conduisant à une déconnexion stérile.
PCT/US2021/063840 2020-12-18 2021-12-16 Déconnexion stérile de systèmes de bioprocédé et son procédé d'utilisation WO2022133105A1 (fr)

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CN202180085213.7A CN116601288A (zh) 2020-12-18 2021-12-16 用于生物处理系统的无菌断开连接以及其使用方法
US18/257,156 US20240026264A1 (en) 2020-12-18 2021-12-16 Sterile Disconnect For Bioprocess Systems and Method For Using Same
EP21848354.3A EP4244330A1 (fr) 2020-12-18 2021-12-16 Déconnexion stérile de systèmes de bioprocédé et son procédé d'utilisation
KR1020237023869A KR20230122078A (ko) 2020-12-18 2021-12-16 바이오프로세스 시스템을 위한 멸균 단절기 및 이의사용 방법
JP2023562456A JP2024500185A (ja) 2020-12-18 2021-12-16 バイオプロセスシステムの無菌的切り離し及びその使用方法

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US5656491A (en) 1992-06-09 1997-08-12 Snamprogettibiotecnologie S.P.A. Mobile-module plant for the development and the production of biotechnological products on a pilot scale
US20030230521A1 (en) * 2002-06-14 2003-12-18 Schick Karl G. Single-use manifold for automated, aseptic transfer of solutions in bioprocessing applications
WO2005076093A1 (fr) * 2004-02-03 2005-08-18 Xcellerex, Llc Systeme et procede de fabrication
US8298054B2 (en) 2004-02-03 2012-10-30 Xcellerex, Inc. System and method for manufacturing
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US20160097074A1 (en) 2007-04-16 2016-04-07 Momenta Pharmaceuticals, Inc. Defined glycoprotein products and related methods
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WO2014012584A1 (fr) * 2012-07-18 2014-01-23 Siemens Aktiengesellschaft Dispositif d'analyse permettant d'analyser un fluide dans une poche souple; et récipient de réaction comportant une paroi réalisée en un matériau souple
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US20240026264A1 (en) 2024-01-25

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